GoutPhase 2NCT01052987
Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
A Phase 2 study testing Tranilast, Allopurinol and Combination - Tranilast and Allopurinol in people with Gout and Hyperuricemia, run by Nuon Therapeutics, Inc. at 3 sites in United States.
Trial summary
This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Tranilast, Allopurinol and Combination - Tranilast and Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 21 to 70
- Subjects with hyperuricemia who are otherwise healthy
Who cannot join
- Pregnant or nursing
- Known history of gout unless approved by the Investigator or Sponsor
- Clinically significant infection at Screening
- Known sensitivity to tranilast or allopurinol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nuon Investigative Site
Dallas, Texas
Nuon Investigative Site
Evansville, Indiana
Nuon Investigative Site
Honolulu, Hawaii
About this study
Official title: A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Allopurinol Compared With Tranilast Alone and Allopurinol Alone in Healthy Subjects With Hyperuricemia
This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.
- Conditions
- Gout, Hyperuricemia
- Being tested
- Tranilast, Allopurinol, Combination - Tranilast and Allopurinol, 400 mg Allopurinol, High dose combination
- Keywords
- Gout, Hyperuricemia
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranilastDrug
Tranilast tablets, 300 mg, QD
AllopurinolDrug
Allopurinol tablets 300 mg, QD
Combination - Tranilast and AllopurinolDrug
Tranilast, 300 mg QD; Allopurinol 300 mg QD
400 mg AllopurinolDrug
400 mg Allopurinol administered once daily for 7 days
High dose combinationDrug
Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Tranilast | Experimental | Tranilast tablets Receives: Drug: Tranilast |
| Allopurinol | Active comparator | Allopurinol tablets Receives: Drug: Allopurinol |
| Combination | Experimental | Tranilast plus Allopurinol Receives: Drug: Combination - Tranilast and Allopurinol |
| High dose Allopurinol | Active comparator | 400 mg Allopurinol Receives: Drug: 400 mg Allopurinol |
| High dose combination | Experimental | Combination of Tranilast 300 mg and Allopurinol 400 mg Receives: Drug: High dose combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent decrease in serum uric acid levels
Measured: Seven days
Secondary outcomes (1)
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Director, Nuon Clinical Trials Group, Study director, Nuon Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052987
- Sponsor's protocol ID
- A3008GT
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2010
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Allopurinol Compared With Tranilast Alone and Allopurinol Alone in Healthy Subjects With Hyperuricemia
- ClinicalTrials.gov ID
- NCT01052987
- Acronym / sponsor ID
- A3008GT
- Conditions
- Gout, Hyperuricemia
- Keywords
- Gout, Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nuon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tranilast | Experimental | Drug: TranilastTranilast tablets |
| Allopurinol | Active comparator | Drug: AllopurinolAllopurinol tablets |
| Combination | Experimental | Drug: Combination - Tranilast and AllopurinolTranilast plus Allopurinol |
| High dose Allopurinol | Active comparator | Drug: 400 mg Allopurinol400 mg Allopurinol |
| High dose combination | Experimental | Drug: High dose combinationCombination of Tranilast 300 mg and Allopurinol 400 mg |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, aged 21 to 70
- Subjects with hyperuricemia who are otherwise healthy
Key exclusion criteria (4 listed)
- Pregnant or nursing
- Known history of gout unless approved by the Investigator or Sponsor
- Clinically significant infection at Screening
- Known sensitivity to tranilast or allopurinol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TranilastTranilast tablets, 300 mg, QD | Drug | Tranilast |
| AllopurinolAllopurinol tablets 300 mg, QD | Drug | Allopurinol |
| Combination - Tranilast and AllopurinolTranilast, 300 mg QD; Allopurinol 300 mg QD | Drug | Combination |
| 400 mg Allopurinol400 mg Allopurinol administered once daily for 7 days | Drug | High dose Allopurinol |
| High dose combinationCombination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days | Drug | High dose combination |
Primary outcome
Mean percent decrease in serum uric acid levels
Time frame: Seven days
1 secondary outcome
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination
Time frame: Seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director, Nuon Clinical Trials Group study director
Nuon Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranilast, Allopurinol and Combination - Tranilast and Allopurinol in people with Gout and Hyperuricemia, run by Nuon Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent decrease in serum uric acid levels (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2011.